Malaria in Early Life Study

• Status: Completed
• Trial end date: 2017-05-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effectiveness of different malaria control strategies in the first year of life.

The effectiveness of delivering an intermittent screening and treatment programme with dihydroartemisinin-piperaquine (DHP), linked to local immunization programmes, will be compared to the current practice of passive case detection of malaria.

This study has two objectives:

1. To assess the effectiveness of intermittent screening and treatment with dihydroartemisinin-piperaquine (DHP) administered at 2, 3, 4 and 9 months of age compared with the current practice of passive detection and treatment for malaria in an area with high drug resistance levels to both P. falciparum and P. vivax.

2. To evaluate the safety, efficacy and population pharmacokinetics of DHP in children under 1 year of age.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gadjah Mada University
• Collaborators: Eijkman Institute for Molecular Biology; Eijkman Institute, Jakarta, Indonesia; Menzies School of Health Research; Timika Research Facility, Indonesia
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine

Criteria

Inclusion Criteria:

• Mother of participant is enrolled in the STOP MiP trial

• Healthy full term newborn of consenting parent

• Residence in the study area for the duration of the follow up period

Exclusion Criteria:

• Preterm infants (<37 weeks gestation)

• Sick newborns, requiring hospitalization